Stability‐indicating methods for the determination of mosapride citrate in the presence of its degradation products according to ICH guidelines

Abstract

In the present work, different spectrophotometric methods and one spectrofluorimetric method have been developed and validated for the determination of mosapride citrate in the presence of its acid-induced degradation products. The drug was subjected to stress stability study including acid, alkali, oxidative, photolytic, and thermal stress degradation. The developed spectrophotometric methods included the use of first order derivative ((1)D), derivative of ratio spectra ((1)DD), mean centring of ratio spectra (MC) and H-point standard additions (HPSAM) spectrophotometric methods. For (1)D method, the peaks amplitudes at 282.8 and 319.6 nm were measured, while for (1)DD method those at 308 nm and 323 nm were measured. Mean centring of ratio spectra method used the values at 317 nm for calibration, while for HPSAM the absorbance at 273 and 288.6 nm were used. These methods were successfully applied for determination of mosapride in the concentration range of 5-70 µg.ml(-1). The spectrofluorimetric method was based on measuring the native fluorescence of mosapride in 0.1 M NaOH using λ(excitation) 276 nm and λ(emission) 344 nm and 684 nm with linearity ranges of 50-3000 ng.ml(-1) and 50-9000 ng.ml(-1), respectively. All the developed methods were validated according to the International Conference on Harmonization (ICH) guidelines and were applied for bulk powder and dosage form. The results obtained were statistically compared to each other using one-way ANOVA testing.

Stability-Indicating Chromatographic Methods for Simultaneous Determination of Mosapride and Pantoprazole in Pharmaceutical Dosage Form and Plasma Samples

“…A stability-indicating method has been studied and validated for the determination of mosapride citrate, as the drug has both amide and ether linkages which are susceptible to acid hydrolysis by the effect of 2 M at 120°C to give two main degradation products [7] (Fig. 1, a1, a2).…”

“…Stability-indicating methods for the analysis of mosapride [7] and pantoprazole [8] were reported. Only one spectroscopic method was reported for their simultaneous determination in dosage form [9].…”

Different Mathematical Spectrophotometric Methods for Determination of Ampyrone in Presence of Its Acid Degradation Product

“…0.025 gm of pure Ampyrone was refluxed with 250 mL 2N HCl for 60 min. After cooling, the solution was evaporated to dryness by oven at 70 °C, the solid residue was extracted with ethanol, filtered into 250 mL volumetric flask completed to the mark with distilled water to obtained a solution contain an acidic product derivative 1000 mg/L of Ampyrone [16,17], transferred 25 mL of this solution into 250 mL volumetric flask, complete to the mark with distilled water to make solution contain acidic product derivative 100 mg/L of Ampyrone (Figure 1).…”